Regulations and Approvals Expert Working Group (RA-EWG) is an industry association driven expert working group promoting regulatory convergence, with the ultimate goal of expediting the launch of innovative medicine in Asia.
Through close collaboration among 13 member associations, RA-EWG aims at making practical proposals for our stakeholders -regulatory authorities and applicants in each economy - on shared regulatory issues in Asia.
Specifically, RA-EWG engages in the following two tasks in close collaboration with Asian regulatory authorities.
Task A: Good Registration Management
・Introduction of Good Submission Practice (GSubP)
APAC Good Submission Practice (GSubP) guideline is a document for best practices proposed by RA-EWG under the concept of Good Registration Management, aiming at improving the quality of submission.
・Promote Good Review Practice (GRevP) by making proposals (APAC Position paper)
APAC Position Paper is to provide high level suggestions and proposals to regulatory authorities from the viewpoint of industry.
Task B: Convergence of NDA requirements
・Make Proposals to facilitate regulatory convergence of NDA requirements based on gap analysis.
We hope these activities would contribute to realizing regulatory convergence in NDA/Approval processes and eventually leading to mutual acceptance of NDA review reports or co-review among regulatory authorities.
Member associations of Regulations and Approvals Expert Working Group (RA-EWG) are as follows:
R&D-based Pharmaceutical Association in China
The Hong Kong Association of the Pharmaceutical Industry
Organization of Pharmaceutical Producers of India
International Pharmaceutical Manufacturers Group
Japan Pharmaceutical Manufacturers Association
Korea Pharmaceutical Manufacturers Association
Korean Research-based Pharmaceutical Industry Association
Pharmaceutical Association of Malaysia
The Pharmaceutical and Healthcare Association of the Philippines
Singapore Association of Pharmaceutical Industries
International Research-Based Pharmaceutical Manufacturers Association
The Pharmaceutical Research and Manufacturers Association
|Vietnam||Pharma Group (associate)
European Chamber of commerce in Vietnam
RA-EWG works closely with Ministries of Health/Regulatory Authorities and member associations to promote regulatory convergence in Asia. (Please refer to “Stakeholder links” for the full list)